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HIGHLIGHTS FROM THE 2024 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY ANNUAL MEETING |
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Presidential Symposium I: Practice-Changing Trials
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| Radium-223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Patients with Bone Metastatic Castration-Resistant Prostate Cancer: First Results of EORTC-GUCG 1333/PEACE-3
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| Silke Gillessen Sommer, MD
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| Silke Gillessen Sommer presents the phase III PEACE-3 trial results, which evaluated the combination of radium-223 and enzalutamide in asymptomatic or mildly symptomatic patients with bone mCRPC. The combination significantly improved radiographic progression-free survival and overall survival compared to enzalutamide alone. |
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| Invited Discussant – EORTC-GUCG 1333/PEACE-3
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| Karim Fizazi, MD, PhD
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| Karim Fizazi discusses the PEACE-3 trial results, which demonstrated that combining radium-223 with enzalutamide significantly improved rPFS and potentially overall survival in asymptomatic or mildly symptomatic patients with bone mCRPC. While the combination showed a clinical benefit, Dr. Fizazi highlighted the need for bone-protecting agents to prevent fractures, and stressed that more data, particularly on long-term overall survival and osteonecrosis of the jaw, are required.
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Biochemical Failure Post-Local Therapy: An Opportunity for Tailored Treatment?
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| Intensification of Systemic Treatment for Poor Risk Disease
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| Dana Rathkopf, MD
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| Dana Rathkopf addresses the intensification of systemic treatment in poor-risk prostate cancer patients experiencing biochemical recurrence after curative intent treatment. She discussed the evolving definitions of high-risk BCR across different guidelines, emphasizing the 2024 NCCN guidelines, which incorporate multivariable models like gene expression classifiers and AI-based digital histopathology biomarkers for improved risk stratification.
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| PSMA PET as a Game Changer for Decision Making?
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| Daniela-Elena Oprea-Lager, MD, PhD
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| Daniela Oprea-Lager highlights PSMA PET as a transformative tool in managing prostate cancer, especially for patients experiencing biochemical failure after local therapy. PSMA PET enables more precise localization of cancer lesions, significantly improving treatment planning and decision-making compared to conventional imaging.
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| Xaluritamig, a STEAP1 x CD3 XmAb 2+1 Immune Therapy, in Patients With mCRPC: Initial Results From Dose Expansion Cohorts in a Phase 1 Study
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| William Kelly DO
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| William Kelly presents the results from a Phase 1 study of xaluritamig, a bispecific T-cell engager targeting STEAP1, in patients with mCRPC. The study showed promising antitumor activity, with a 49% PSA50 response rate and a 24% objective response rate, particularly at higher doses.
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| Symptomatic Skeletal Events, Health-Related Quality of Life and Pain in a Phase 3 Study of [177Lu]Lu-PSMA-617 in Taxane-Naive Patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer: Third Interim Analysis of PSMAfore |
| Karim Fizazi, MD, PhD |
| Karim Fizazi presents the third interim analysis of the PSMAfore Phase 3 trial, comparing 177Lu-PSMA-617 radioligand therapy to androgen receptor pathway inhibitor change in taxane-naive patients with PSMA-positive mCRPC. The study showed that 177Lu-PSMA-617 significantly delayed symptomatic skeletal events, health-related quality of life deterioration, and pain worsening compared to ARPI change. |
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| First Results from ZZFIRST: a Randomized Phase II Trial of Enzalutamide with or without Talazoparib in Metastatic Hormone-naïve Prostate Cancer
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| Joaquin Mateo, MD, PhD
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| Joaquin Mateo presents the first results from the ZZFIRST trial, a Phase II study investigating the combination of enzalutamide with or without talazoparib in metastatic hormone-naïve prostate cancer. This trial is the first to explore this combination in mHNPC, based on the synergy observed between androgen receptor pathway inhibitors and PARP inhibitors in metastatic castration-resistant prostate cancer.
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| PSMA-Targeted Radioligand Therapy with 131I-LNTH-1095 Plus Enzalutamide versus Enzalutamide Alone in Chemotherapy-naïve Patients Whose Piflufolastat F 18-avid Metastatic Castration-resistant Prostate Cancer Progressed on Abiraterone: ARROW
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| Evan Yu, MD
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| The ARROW trial, presented at ESMO 2024, compared PSMA-targeted radioligand therapy plus enzalutamide versus enzalutamide alone in chemotherapy-naïve mCRPC patients progressing on abiraterone. The combination arm demonstrated a significantly higher PSA50 response, although median radiographic progression-free survival showed no significant difference.
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| Opevesostat (MK-5684/ODM-208), an Oral CYP11A1 Inhibitor, in Metastatic Castration-Resistant Prostate Cancer: Updated CYPIDES Phase 2 Results
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| Karim Fizazi, MD, PhD
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| The updated phase II CYPIDES trial results presented at ESMO 2024 showed that opevesostat (ODM-208/MK-5684), an oral CYP11A1 inhibitor, demonstrated promising PSA and RECIST responses in heavily pre-treated mCRPC patients, particularly those with AR-LBD mutations. A PSA50 response was observed in 53% of patients with AR-LBD mutations and 15% in those without.
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| Association of the Lipid Biomarker, PCPro, and Clinical Outcomes in the ENZAMET Trial (ANZUP 1304)
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| Lisa Horvath, MBBS, PhD
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| In the ad hoc analysis of the ENZAMET trial presented at ESMO 2024, Dr. Lisa Horvath explored the association of the lipid biomarker, PCPro, with clinical outcomes in mHSPC patients. The study found that PCPro-positive patients had worse overall and clinical progression-free survival, indicating poorer prognosis.
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| Prostate Cancer Working Group 4 Preliminary Criteria Using Serial PSMA PET/CT for Response Evaluation: Analysis from the PRINCE Trial
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| Michael Hofman, MBBS (Hons), FRACP, FAANMS
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| Michael Hofman presented preliminary criteria from Prostate Cancer Working Group 4 (PCWG4) for using serial PSMA PET/CT in response evaluation. The new criteria showed substantial agreement in assessing response levels and nearly perfect agreement in distinguishing progressive from non-progressive disease.
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| PSMA-PET and PROMISE Re-Define Stage and Risk in Patients with Prostate Cancer |
| Wolfgang Fendler, MD |
| Wolfgang Fendler presented findings on the prognostic value of PSMA-PET using PROMISE criteria compared to established clinical risk scores in prostate cancer. The study involved over 2,400 patients and showed that both quantitative and visual PSMA-PET PROMISE nomograms were superior in predicting overall survival compared to traditional risk scores like STARCAP, EAU, and NCCN. |
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| Final Safety and Efficacy Analysis of RaLu: 177Lu-PSMA Therapy in Patients with Prior Radium‑223 |
| Kambiz Rahbar, MD |
| At ESMO 2024, Kambiz Rahbar presented data from the RaLu study, which examined the safety and efficacy of 177Lu-PSMA therapy in patients with metastatic castration-resistant prostate cancer who had previously been treated with radium-223. The study, involving 198 patients, demonstrated that 177Lu-PSMA is feasible and effective after radium-223, with common adverse events being hematological, and highlighted the potential for optimizing treatment sequencing in clinical practice. |
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| SAABR: Single Arm Phase II Study of Androgen Receptor Pathway Inhibitor + Atezolizumab + GnRH analog and Stereotactic Body Radiotherapy to the Prostate in Men with De Novo Hormone-sensitive Metastatic Prostate Cancer
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| Dana Rathkopf, MD
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| Dana Rathkopf presented findings from the SAABR trial, a Phase II study investigating the combination of atezolizumab, an androgen receptor pathway inhibitor, a GnRH analog, and stereotactic body radiotherapy in newly diagnosed mHSPC. While the combination showed modest activity with 69% of patients free from failure at two years and some PSA responses to atezolizumab alone, the regimen also led to significant toxicity.
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